REMIDENT
Research type
Research Study
Full title
A phase III randomised, triple-blind controlled superiority trial of remimazolam (CNS 7056), compared to midazolam, in adults having lower third molar wisdom tooth extraction under intravenous conscious sedation to assess cognitive and motor recovery at normal discharge times.
IRAS ID
1003587
Contact name
Bryan Kerr
Contact email
Sponsor organisation
Guy's and St Thomas NHS Foundation Trust
Eudract number
2020-005121-89
ISRCTN Number
ISRCTN35903062
Clinicaltrials.gov Identifier
Research summary
We want to know if a new drug that is used to sedate and relax adults 18-59 years having dental treatment is better than the current drug we use.
Intravenous sedation is where a drug is injected into a patient’s hand or arm. The drug stops them feeling worried, and helps them relax.
After sedation patients wait in a recovery area until they are safe to walk but the side effects of the drug can last until the next day.
A new drug is in development that has the same sedation effect and safety, but the recovery is much quicker. We think that the side effects from the new drug will have worn off by the time patients are ready to leave the hospital. We will ask patients who are coming to Guy’s Hospital to have their wisdom tooth extracted under sedation if they want to be included in the research.
The sedation and dental treatment will be carried out in the normal way.The patients will be asked to do will be some questionnaires and some tests which are as follows:
Patients are asked to listen to some words and repeat them back. This tests how well they can remember new information
2) Reaction test
Patients are asked to rest their fingers on a keypad and move their fingers when lights come on above them. This tests how quick their reactions are.
3) Symbol test
Patients are asked to draw small shapes that are linked to numbers. This tests how well they can process information.
4) Standing test
Patients are asked to stand on a platform that measures how much they are swaying back and forth. This tests how stable they are to walk.
By testing people before and after the sedation we can see how they recovered and compare the two drugs.
The research will take place during the day case visit and involve 2 x 30 mins research assessments and the time points of these – e.g. undertaking the measures before sedation and post sedation, after which time participants will be discharged, followed by a telephone review 3-10 days post procedure.REC name
West of Scotland REC 1
REC reference
21/WS/0105
Date of REC Opinion
1 Oct 2021
REC opinion
Further Information Favourable Opinion